PI3K Inhibitor Fails to Pass Muster With FDA Advisory Committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) made a clean sweep of its 2-day meeting, deciding that the PI3K inhibitor duvelisib (Copiktra) does not offer a favorable risk-benefit ratio for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). By an 8-4 vote, the panel came down on the side of the FDA […]
Zanubrutinib Tops Ibrutinib in Relapsed or Refractory CLL
Treatment with the second-generation Bruton tyrosine kinase (BTK) inhibitor led to better oncologic outcomes compared with ibrutinib (Imbruvica) for patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), according to an interim analysis of the phase III ALPINE study. Over a median follow-up of 15 months, the overall response rate — the primary […]